STRYKER X7000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-19 for STRYKER X7000 * manufactured by Stryker Endoscopy.

Event Text Entries

[470359] Fiberoptic light source failed during shoulder arthroscopy procedure. Surgeon was unable to see surgical site. A defective fiberoptic cable was replaced by biomed, resolving the problem. The case resumed and was completed. We have had numerous identical failures with this model light source/light cable.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number709918
MDR Report Key709918
Date Received2006-04-19
Date of Report2006-04-07
Date of Event2006-04-07
Report Date2006-04-07
Date Reported to FDA2006-04-19
Date Added to Maude2006-05-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameSTRYKER
Generic NameLIGHT SOURCE
Product CodeFSW
Date Received2006-04-19
Model NumberX7000
Catalog Number*
Lot Number*
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Age1 YR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key698964
ManufacturerSTRYKER ENDOSCOPY
Manufacturer Address5900 OPTICAL COURT SAN JOSE CA 95138 US

Device Sequence Number: 2

Brand Name*
Generic NameFIBEROPTIC CABLE
Product CodeFSW
Date Received2006-04-19
Model Number*
Catalog Number*
Lot Number*
ID Number*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key698965
ManufacturerSTRYKER ENDOSCOPY
Manufacturer Address5900 OPTICAL COURT SAN JOSE CA 95138 US

Patients

Patient NumberTreatmentOutcomeDate
10 2006-04-19
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